Beschreibung

Kursart

Seminar

Methodik

Online

Our online course about regulatory strategy, steps and timelines for global medical device market access with an eye on the Americas, the Asian Pacific and China. Get your practice now!

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Meinungen

Erfolge dieses Bildungszentrums

2020

Wie bekomme ich das CUM-LAUDE-Siegel?

Sämtlich Kurse sind auf dem neuesten Stand

Die Durchschnittsbewertung liegt über 3,7

Mehr als 50 Meinungen in den letzten 12 Monaten

Dieses Bildungszentrum ist seit 16 Mitglied auf Emagister

Themen

Health Sciences
China
Access
Audit

Inhalte

Detailed programme

Module 1: June 16 / 10:00 - 13:00;
Module 2: June 17 / 10:00 - 12:00;
Module 3: June 18 / 10:00 - 11:00;
Dial-in each morning: 09:30

Module 1: Regulatory strategy and the Americas

How to control market authorization assets
Preparation and post approval considerations
Impact of the Medical Device Single Audit Program (MDSAP)
Canadian Medical Devices Regulations (CMDR)
Brazil: ANVISA and INMETRO requirements and market access procedure
Registration in Argentina and Mexico

Module 2: China

China's National Medical Products Administration (NMPA): Responsibilities and structure
Overview of laws, regulations and guidelines
Approval steps and timeline according to risk class
Practical experience

Module 3: The Asia-Pacific region

Taiwan FDA (TFDA) registrations
Singapore Health Sciences Authority (HSA) approvals
Malaysia Medical Device Authority (MDA) procedure
NA-DFC Indonesia requirements

Detailed programme

Module 1: June 16 / 10:00 - 13:00;
Module 2: June 17 / 10:00 - 12:00;
Module 3: June 18 / 10:00 - 11:00;
Dial-in each morning: 09:30

Module 1: Regulatory strategy and the Americas

How to control market authorization assets
Preparation and post approval considerations
Impact of the Medical Device Single Audit Program (MDSAP)
Canadian Medical Devices Regulations (CMDR)
Brazil: ANVISA and INMETRO requirements and market access procedure
Registration in Argentina and Mexico

Module 2: China

China's National Medical Products Administration (NMPA): Responsibilities and structure
Overview of laws, regulations and guidelines
Approval steps and timeline according to risk class
Practical experience

Module 3: The Asia-Pacific region

Taiwan FDA (TFDA) registrations
Singapore Health Sciences Authority (HSA) approvals
Malaysia Medical Device Authority (MDA) procedure
NA-DFC Indonesia requirements

Detailed programme

Module 1: June 16 / 10:00 - 13:00;
Module 2: June 17 / 10:00 - 12:00;
Module 3: June 18 / 10:00 - 11:00;
Dial-in each morning: 09:30

Module 1: Regulatory strategy and the Americas

How to control market authorization assets
Preparation and post approval considerations
Impact of the Medical Device Single Audit Program (MDSAP)
Canadian Medical Devices Regulations (CMDR)
Brazil: ANVISA and INMETRO requirements and market access procedure
Registration in Argentina and Mexico

Module 2: China

China's National Medical Products Administration (NMPA): Responsibilities and structure
Overview of laws, regulations and guidelines
Approval steps and timeline according to risk class
Practical experience

Module 3: The Asia-Pacific region

Taiwan FDA (TFDA) registrations
Singapore Health Sciences Authority (HSA) approvals
Malaysia Medical Device Authority (MDA) procedure
NA-DFC Indonesia requirements

Module 1: Regulatory strategy and the Americas

How to control market authorization assets
Preparation and post approval considerations
Impact of the Medical Device Single Audit Program (MDSAP)
Canadian Medical Devices Regulations (CMDR)
Brazil: ANVISA and INMETRO requirements and market access procedure
Registration in Argentina and Mexico

Module 2: China

China's National Medical Products Administration (NMPA): Responsibilities and structure
Overview of laws, regulations and guidelines
Approval steps and timeline according to risk class
Practical experience

Module 3: The Asia-Pacific region

Taiwan FDA (TFDA) registrations
Singapore Health Sciences Authority (HSA) approvals
Malaysia Medical Device Authority (MDA) procedure
NA-DFC Indonesia requirements

Module 1: Regulatory strategy and the Americas

How to control market authorization assets
Preparation and post approval considerations
Impact of the Medical Device Single Audit Program (MDSAP)
Canadian Medical Devices Regulations (CMDR)
Brazil: ANVISA and INMETRO requirements and market access procedure
Registration in Argentina and Mexico

Module 1: Regulatory strategy and the Americas

How to control market authorization assets
Preparation and post approval considerations
Impact of the Medical Device Single Audit Program (MDSAP)
Canadian Medical Devices Regulations (CMDR)
Brazil: ANVISA and INMETRO requirements and market access procedure
Registration in Argentina and Mexico

Module 1: Regulatory strategy and the Americas

How to control market authorization assets
Preparation and post approval considerations
Impact of the Medical Device Single Audit Program (MDSAP)
Canadian Medical Devices Regulations (CMDR)
Brazil: ANVISA and INMETRO requirements and market access procedure

Verwandte Kategorien

Kontakt

Global Medical Device Registration

Fragen & Antworten

Meinungen

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Themen

Inhalte

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